Abstract

Problem: This study estimated the safety and effectiveness of surgery to relieve the symptoms associated with rhinosinusitis and nasal polyposis. Methods: For this study 3128 consecutive patients undergoing surgery for nasal polyposis or rhinosinusitis at 87 hospitals were prospectively enrolled. Data on patient prognostic factors were collected at the time of surgery. Outcomes data were collected at 3, 12, and 36 months postsurgery. A patient-centered outcome instrument, the SNOT-22, was used as the main outcome measure. Data on patient satisfaction, revision surgery, and adverse events were also collected. Results: There were no adverse events reported in 93.4% of procedures. The CSF leak rate was 0.064% and the periorbital haematoma rate was 0.2% with no long-term visual problems. There is a statistically significant decrease in patient-reported symptomatology as measured by the SNOT-22 from the preoperative period to both 3 and 12 months. The average effect size at 12 months was 0.7 SD. Asthma, previous surgery, and less extensive polyposis were the strongest independent predictors of higher postoperative symptomatology in a multivariate analysis. Nearly one third of patients undergoing sinus surgery had Lund-Mackay scores less than 4, lower than the normal population. In 3.9% of the patients surgery was performed in the virtual absence of symptoms, and 8.6% of the patients had had or were awaiting revision surgery at 12 months. Full results for the 36-month follow-up period are currently being analyzed and will be presented. Conclusion: Sino-nasal surgery is generally safe and effective. Greatest symptom reduction is seen with primary surgery for patients with extensive nasal polyposis. Greater attention should be paid to patient-reported symptoms when selecting patients for surgery. Significance: This is the largest study of its kind to date and provides a unique estimate of the safety and effectiveness of sino-nasal surgery from the perspective of the patient. Support: The study was funded by a standard contribution from each participating hospital. Funding was also received from the British Association of Otorhinolaryngologists-Head and Neck Surgeons and from GlaxoSmithKline Ltd.

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